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Recall Observatory FDA recall evidence

Drug product

Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.

D-1535-2022

September 12, 2022

Class II

Product summary

Firm
Direct Rx
Event
Event 90869
Status
Completed
Classification
Class II
Quantity
20 tubes
Official record key
drug-enforcement:D-1535-2022

Official wording

Reason: CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.

Code information: Lot: 12JY2216, Exp. 2/29/24

Distribution pattern: Physicians and Medical Facilities in GA and ID

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations